NIDDK Humanized Mice studies

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), intends to award a purchase order without providing for full and open competition to Bioqual, Inc. 9600 Medical Center Drive, Rockville, Maryland 20850-3336, for NIDDK Humanized Mice Studies NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541715 with a Size Standard 1000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2022-07 effective 08-10-2022. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12- Acquisition of Commercial Items. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13'Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6'Competition Requirements. Place of Performance National Institutes of Health 9000 Rockville Pike Bethesda MD 20892 United States DESCRIPTION OF REQUIREMENT The objective of this request is to procure lab testing services for mice studies to expand viral particles and measure infectious virus titers, required to determine the viral load necessary for robust infection in humanized mice. Infection will be measured by PCR and flow cytometry of T-cells in infected and control mice. In-life blood collections will be conducted on SD 0, 7, 14, and 21. Terminal Blood collections will be conducted on SD 28 for all mice. In the second study, the objective is to obtain the HIV infection protection data for the NPCS developed Drug candidate Fc-GRFT as a prerequisite for future pre-clinical testing in non-human primates. The level of HIV infection needed will have been determined in study (1). Two test points will be measured Injecting compound Fc-GRFT 24 hours before HIV challenge and injecting compound Fc-GRFT at the same time as HIV challenge. In-life blood collections will be conducted on SD 0, 7, 14, and 21. Terminal Blood collections will be conducted on SD 28 for all mice. REQUIRED FEATURES AND SPECIFICATIONS (Study 1) to determine HIV titers necessary for infection. (Study 2) antibody protein-conjugate, called Fc-mGRFT, will be tested in the HIV infection model established in Study 1. Study 1 : 9 CD34 & NSG mice between the ages of 6-8 weeks old from an approved vendor. The mice (N=9) will be split into 3 groups of 3 mice each (N=3/group). All mice will be challenged on SD 0 with HIV via intraperitoneal (IP) injection. In-life blood collections will be conducted on SD 0, 7, 14, and 21. Terminal Blood collections will be conducted on SD 28 for all mice. During the challenge period, clinical observations will be recorded BID and weights will be recorded daily. Infection will be measured by PCR and flow cytometry of T-cells in infected and control mice. Study 2: 12 CD34 & NSG mice between the ages of 6-8 weeks old from an approved vendor. The mice (N=12) will be split into 4 groups of 3 mice each (N=3/group). Mice from groups 1 and 2 will be treated on SD -1 via intramuscular (IM) injection (24h pre-challenge). Mice from groups 3 and 4 will be treated on SD 0 (pre-challenge). All mice will be challenged on SD 0 with HIV via intraperitoneal (IP) with dosage based on results of Study 1. In-life blood collections will be conducted on SD 0, 7, 14, and 21. Terminal Blood collections will be conducted on SD 28 for all mice. Infection will be measured by PCR and flow cytometry of T-cells in infected and control mice. Task Area 1 - Serum Data - The Contractor shall provide data from PCR and flow cytometry of T-cells in infected mice from each bleed to the NPCS by either electronic transfer or hard copy mail as needed. Task Area 2 - Final Report - The Contractor shall provide a final report via email (to be scheduled by Project Officer); billed upon receipt of the first draft. The anticipated period of performance is: 9/16/2022 - 9/15/2023. The Contractor shall provide the services contingent upon test system availability. Amounts for animal purchases are due at contract signing. Procedures and per diem will be billed each month as incurred. Administration/Management will be billed monthly on a prorated basis until the end of in-life. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND- NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10'Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined that Bioqual, Inc. is the only vendor that can provide the specialized pre-clinical and clinical evaluation of pharmaceuticals and has successfully completed NIH studies in the past. BioQual has worked extensively on HIV/AIDS drugs in cooperation with NIH researchers including NIDDK, NCI, NIAID, and the Vaccine Research Center. They have shown great care and reliability in carrying out these very important and sensitive animal studies. Bioqual holds AAALAC accreditation (file # 624) and is Animal Welfare Assurance compliant with an OLAW-approved Assurance Number A-3086-01. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provided feedback to respondents with respect to any information submitted. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement, unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Vendor/Contractor's (UEI) the Unique Entity ID from SAM.gov is now the authoritative identifier for those doing business with the federal government. The DUNS Number is no longer valid for federal award identification, the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses to this notice (NICHD-22-273) shall be submitted electronically by 11:00 AM Eastern Standard Time, on September 7, 2022. Any questions must be sent via email to contact@example.gov and must include solicitation# NICHD-22-273 in the subject line of email.